Mechanical Circulatory Support Systems Research Articles

Total artificial heart: past, present, and future

Every year, approximately 5 out of 1000 patients receive a diagnosis of advanced heart failure, with a prevalence of 1-2% in the adult population. This figure is likely underestimated, considering undiagnosed cases. Despite significant progress in medical therapy for heart failure, mortality rates persist around 20% within the first year, reaching 50-60% at 5 years from the initial diagnosis. For patients with severe end-stage heart failure, the 1-year mortality rate can reach up to 70%. Heart transplantation remains the preferred treatment for terminal stages of the disease; however, the significant challenge lies in the mismatch between available donors and recipients. Given this dilemma, both short-term solutions including extracorporeal membrane oxygenation and long-term options such as left ventricular assist devices have gained prominence. These mechanical circulatory support systems become crucial for patients in critical conditions, temporarily ineligible for heart transplantation, such as those with severe irreversible pulmonary hypertension or acute organ failure. Despite these advancements, a growing number of patients on the waiting list develops severe biventricular dysfunction, precluding the use of a left ventricular assist device as a bridge to transplant. In such cases, a total artificial heart emerges as a viable therapeutic option.

Role of mechanical circulatory support in VT ablation procedures: data from the German PROTECT VT registry

Abstract Introduction Ventricular tachycardia (VT) ablation in patients with progressed heart failure (HF) is known to be complex and associated with a high periprocedural risk and mortality, in part due due to hemodynamic instability during ongoingVTs. Use of mechanical circulatory support (MCS) systems has been already implemented in complex high-risk percutaneous coronary intervention (CHIP-PCI) workflows. Use and benefit of MCS in VT ablation is still under debate. MCS protected VT ablation (proVT-A) might be associated with improved clinical outcomebut potentially comes along with an increased risk of periprocedural complications. Based on data of four German high-volume centers we aimed to analyze retrospective data on patient characteristics and impact of proVT-A with respect to safety and mid-term efficacy. Methods All patients undergoing proVT-A as a primary approach from four German EP centers were included in the analysis. Use of MCS in bailout scenariosin VT ablation were not included. Patient characteristics, procedural parameters and clinical outcome were evaluated. The primary endpoint was a combined endpoint of VT/VF recurrence and all-cause death. Results 41 patients who underwent proVT-A were included. Mean age was 64±11a, 92% of patients were male (38/41), 65% (27/41) suffered from ischemic cardiomyopathy, mean left ventricular ejection fraction was 33±13%,76% (31/41) of patients presented with a documented hemodynamically not tolerated VT, mean PAAIN-ESD score was 13±7, and 46% (19/41) had a history of a previous VT ablation w/o MCS. During proVT-A procedure at least one VT was inducible and mappable in 35 patients (85%). Acute procedural success was 85%, with only n=6 patients remaining inducible for VT. Mean procedure duration was 245±46min. With respect to periprocedural safety (30days)a total of n=12 relevant procedural complications were reported in 8 patients. This included n=5 vascular access complications, of which n=3 requiring transfusion or surgery. One case of periprocedural death was reported 6h post proVT-A due to PEA. Three patients developed pericardial effusion, one requiring drainage. Freedom from VT/VF was 78% (n=9 VT/VF recurrences) after a mean follow-up (FU) of 15±14 months (figure 1A). Death of any cause occurred in n=9 patients (figure 1B). In summary, after a mean FU of 15±14 months n=16 patients (39%) met the combined endpoint of VT/VF recurrence and all-cause death (figure 1C). Conclusion Patients enrolled in the German PROTECT VT Registry had significant cardiovascular comorbidities and therefore represent a high-risk population for VT ablation. Use of MCS was feasible, comparably safe, associated with high procedural and promising long-term success rate. These results highlight the need for larger registries and future prospective trials evaluating the potential benefit of proVT-A in selected patients. Further, it should be aimed for optimization of periprocedural vascular access site management.

Intensive Care Treatment of Pulmonary Embolism: An Update Based on the Revised AWMF S2k Guideline.

Acute pulmonary embolism (PE) remains a significant cause of morbidity and requires prompt diagnosis and management. The prognosis of affected patients depends on the clinical severity. Therefore, risk stratification is imperative for therapeutic decision-making. Patients with high-risk PE need intensive care. These include patients who have successfully survived resuscitation, with obstructive shock or persistent haemodynamic instability. Bedside diagnostics by means of sonographic procedures are of outstanding importance in this high-risk population. In addition to the treatment of hypoxaemia with noninvasive and invasive techniques, the focus is on drug-based haemodynamic stabilisation and usually requires the elimination or reduction of pulmonary vascular thrombotic obstruction by thrombolysis. In the event of a contraindication to thrombolysis or failure of thrombolysis, various catheter-based procedures for thrombus extraction and local thrombolysis are available today and represent an increasing alternative to surgical embolectomy. Mechanical circulatory support systems can bridge the gap between circulatory arrest or refractory shock and definitive stabilisation but are reserved for centres with the appropriate expertise. Therapeutic strategies for patients with intermediate- to high-risk PE in terms of reduced-dose thrombolytic therapy or catheter-based procedures need to be further evaluated in prospective clinical trials.

Mechanical Circulatory Support Systems in the Management of Ventricular Arrhythmias: A Contemporary Overview.

Ventricular tachycardias (VTs) and electrical storms (ES) are life-threatening conditions mostly seen in the setting of structural heart disease (SHD). Traditional management strategies, predominantly centered around pharmacological interventions with antiarrhythmic drugs, have demonstrated limited efficacy in these cases, whereas catheter ablation is related with more favorable outcomes. However, patients with hemodynamically unstable, recurrent VT or ES may present cardiogenic shock (CS) that precludes the procedure, and catheter ablation in patients with SHD portends a multifactorial intrinsic risk of acute hemodynamic decompensation (AHD), that is associated with increased mortality. In this setting, the use of mechanical circulatory support (MCS) systems allow the maintenance of end-organ perfusion and cardiac output, improving coronary flow and myocardial mechanics, and minimizing the effect of cardiac stunning after multiple VT inductions or cardioversion. Although ablation success and VT recurrence are not influenced by hemodynamic support devices, MCS promotes diuresis and reduces the incidence of post-procedural kidney injury. In addition, MCS has a role in post-procedural mortality reduction at long-term follow-up. The current review aims to provide a deep overview of the rationale and modality of MCS in patients with refractory arrhythmias and/or undergoing VT catheter ablation, underlining the importance of patient selection and timing for MCS and summarizing reported clinical experiences in this field.

Switching from VA-ECMO to a Percutaneous right Ventricular assist device as a Bridge to Recovery in a Case of right Ventricular Myocardial Infarction

Acute right heart failure (RHF) is associated with high morbidity and mortality. Temporary mechanical circulatory support (MCS) is now part of the advanced management strategy for refractory cardiogenic shock (CS). Among such support systems, veno-arterial Extracorporeal Membrane Oxygenation (VA-ECMO) remains the fastest MCS system to set up. The ProtekDuo cannula can be used as a temporary and percutaneous right ventricular assist device (RVAD) in relay with VA-ECMO in the context of prolonged weaning. This case report describes the clinical course of a 69-year-old patient who underwent elective aortic valve replacement surgery complicated by acute RHF due to iatrogenic ligation of the right coronary artery. VA-ECMO was initiated in the context of refractory cardiogenic shock. Faced with prolonged MCS weaning, due to lack of recovery of the right ventricle associated with the absence of any other therapeutic option, a percutaneous RVAD via a ProtekDuo cannula was implanted as a bridge to recovery. The ProtekDuo was gradually weaned while the patient began rehabilitation. The patient was transferred to the medical ward after 5 weeks in the ICU, stayed 5 months in an acute medical setting, went to a rehabilitation center afterward and returned home 6 months after the initial surgery without any neurological sequalae or organ failures. In total, she remained on MCS for 39 days (21 on VA-ECMO and 18 on ProtekDuo). In cases of refractory RHF, after stabilization and organ perfusion restoration under VA-ECMO, it is feasible to switch to a percutaneous RVAD, allowing early mobilization of patients during prolonged MCS weaning until the right ventricle adapts to new loading conditions.

A Dynamic Sheep Model to Induce Pulmonary Hypertension and Right Ventricular Failure.

Decompensated right ventricular failure (RVF) in pulmonary hypertension (PH) is fatal, with limited medical treatment options. Developing and testing novel therapeutics for PH requires a clinically relevant large animal model of increased pulmonary vascular resistance and RVF. This manuscript describes the method to induce an ovine PH-RVF model that utilizes left pulmonary artery (LPA) ligation, progressive main pulmonary artery (MPA) banding, and insertion of an RV pressure line for monitoring. The PA cuff and RV pressure tubing are connected to subcutaneous access ports. This model of PH-RVF is a versatile platform to control not only the disease severity, but also the RV's phenotypic response. Subjects undergo progressive PA band adjustments twice per week for approximately 9weeks with sequential measures of RV pressure, PA cuff pressures, and mixed venous blood gas (SvO2). Subjects can further be exercised on a livestock treadmill while hemodynamic parameters are captured. At the initiation and endpoint of this model, ventricular function and dimensions are assessed using echocardiography. In this model, RV mean and systolic pressure increased to 28±5 and 57±7mmHg at week 1, and further to 44±7 and 93±18mmHg by week 9, respectively. Echocardiography demonstrates characteristic findings of PH-RVF, notably RV dilation, increased wall thickness, and septal bowing. The rate of PA banding has a significant impact on SvO2 and thus the model can be titrated to elicit varying RV phenotypes. When the PA cuff is tightened rapidly, it can lead to a precipitous decline in SvO2, leading to RV decompensation, whereas a slower, more paced strategy leads to an adaptive RV stress-load response that maintains physiologic SvO2. A faster rate of PA banding will also lead to more severe liver fibrosis. The addition of controlled exercise provides a useful platform for assessing the effects of physical exertion in a PH-RVF model. This chronic PH-RVF model provides a valuable tool for studying molecular mechanisms, developing diagnostic biomarkers, and evaluating mechanical circulatory support systems.

Volume-outcome relationships for extracorporeal membrane oxygenation in acute myocardial infarction.

Acute myocardial infarction (MI) is one of the major scenarios of extracorporeal membrane oxygenation (ECMO) use. The utilization of mechanical circulatory support systems including ECMO varies widely at the hospital level, while whether ECMO volume per hospital is associated with outcomes in acute MI is unclear. Using a Japanese nationwide administrative database, a total of 26,913 patients with acute MI undergoing percutaneous coronary intervention from 154 hospitals were included. The relations among PCI volume for acute MI, observed and predicted in-hospital mortality, and observed and predicted rates of ECMO use were evaluated at the hospital level. Of 26,913 patients, 423 (1.6%) were treated with ECMO, and 1561 (5.8%) died during the hospitalization. Median ECMO use per hospital per year was 0.5. An observed rate of ECMO use was linearly correlated with the predicted probability of ECMO use and was not associated with the observed/predicted in-hospital mortality ratio. The observed/predicted mortality ratio was lowest in hospitals with the observed/predicted ECMO use ratio of around one. In conclusion, ECMO was infrequently used in a setting of acute MI at each hospital annually. An observed rate of ECMO use was not associated with observed/predicted in-hospital mortality ratio, while the observed/predicted in-hospital mortality ratio was lowest when ECMO was used as predicted, suggesting that standardized ECMO use may be an institutional quality indicator in acute MI.

Implantation of HeartMate III ventricular assist devices in children after surgical treatment of complex congenital heart defect: first experience

Background. There is quite a high number of patients with advanced heart failure (HF) who have undergone surgical treatment for complex congenital heart defects. Implantation of mechanical circulatory support systems is the only treatment option for patients with refractory end-stage heart failure. Only a few centers have experience in implantation of ventricular assist devices (VAD) in children, which is a major challenge for modern pediatric cardiac surgery. Objective: to present our first experience of implantation of HeartMate III VADs in patients after surgical correction of complex congenital heart defects. Materials and methods. From 2021 to 2022, at Bakulev Center for Cardiovascular Surgery, four HeartMate III systems were implanted in children with advanced HF, who had previously undergone surgery for a complex congenital heart defect. In one case, aortic valve implantation was carried out simultaneously with VAD implantation. Results. All patients were discharged from the center. One patient developed right-sided heart failure intraoperatively, which required the use of a right ventricular assist device (RVAD) for 8 days. There were no complications from the central nervous system, bleeding, pump thrombosis, or infection. Conclusion. HeartMate III can be implanted in patients with body weight ≥21 kg and BSA ≥0.88 m2 . Children’s tolerance to physical activity increases, they are fully adapted socially, and can attend school.

Association of inflammation with shock severity, 30-day mortality and therapy response in patients with cardiogenic shock

Abstract Background Elevated concentrations of C-reactive protein (CRP) and other circulating cytokines are often found in cardiogenic shock (CS). The role of systemic inflammation in the pathogenesis of cardiogenic shock remains unclear. To address this, associations between elevated plasma CRP concentrations upon admission with shock severity, 30-day mortality, and therapy response were analysed in patients with CS. Methods Plasma CRP concentrations were identified in a large data base containing unselected patients admitted with cardiogenic shock. The association between plasma CRP concentrations and CS severity (SCAI stage, reference SCAI B) was analyzed using adjusted linear and logistic regression models. The association between plasma CRP concentrations and 30-day mortality was analyzed using adjusted Cox regression models. The interaction between plasma CRP concentrations and treatment response was assessed by fitting an interaction term between plasma CRP concentrations and the use of mechanical circulatory support (MCS) in the above described Cox regression models. Results A total of 1116 patients were analysed. Median age was 70 years [interquartile range 58-78.6 years], 71.3% were male, 47.7% presented with CS due to acute myocardial infarction, and 58.3% with prior cardiac arrest. The median plasma CRP concentration was 17 mg/dl [interquartile range 5.0-71.0 mg/dl]. Plasma CRP concentrations were equally distributed among patients with higher vs. lower shock severity (higher SCAI stage). After adjustment for CS severity and other cofounders, higher plasma CRP concentrations were associated with higher 30-day mortality [8% relative risk increase per 50 mg/dl increase in plasma CRP, range 3-13%, adjusted p<0.001]. The association of plasma CRP concentration and 30-day mortality was abolished in patients treated with MCS [HR for CRP>median: MCS use 0.92 (95%-CI: 0.67-1.26; p=0.59)], while plasma CRP concentration was associated with 30-day mortality in patients not treated with MCS [HR for CRP>median 1.50 (95%-CI: 1.21-1.86; p<0.001); p-interaction=0.01]. Conclusion Increased concentrations of inflammatory cytokines are associated with a higher 30-day mortality regardless of shock severity. This association is abolished when mechanical circulatory support systems are used, potentially by providing sufficient end-organ perfusion. This interaction calls for further research on this topic.

Transition from temporary microaxial left ventricular assist devices to durable mechanical circulatory support systems

Abstract Background Circulatory support with a catheter-based microaxial temporary left ventricular assist device (tLVAD) plays a major role in the treatment of severe cardiogenic shock. In most patients who fail to recover while on temporary mechanical circulatory support (tMCS), durable left ventricular assist device (dLVAD) therapy is usually considered a reliable option. The aim of this study was to identify outcome predictors after the transition from a catheter-based microaxial tLVAD to dLVAD. Methods This is a retrospective analysis of data from a multicentre registry on patients who were transitioned from a catheter-based microaxial tLVAD to a dLVAD between 01/2017 and 10/2022 (n=341) from 19 European high-volume centres with regard to survival and outcome up to one year after dLVAD implantation. Results Patients were supported with an Impella 5.5 (92), 5.0 (155), CP (92), or 2.5 (2) and transitioned to Heartmate 3 (205), a HeartWare HVAD (129) or EXCOR VAD (7) during the same period. The Impella was implanted via the axillary artery in 245 (71.8%), the femoral artery in 93 (27.3%), and via direct access to the aorta in three (0.9%) patients. One hundred and thirty-three (40.5%) patients additionally required extracorporeal life support before and/or during Impella therapy. The aetiology of cardiogenic shock necessitating tMCS was most commonly acute myocardial infarction (31.7%), followed by acute decompensation of ischaemic (28.4%) or dilated cardiomyopathy (27.0%). The 30-day and 1-year survival were 87% and 70%, respectively. The uni- and multivariable analysis included 312 patients with an at least 1-year follow-up or death within the first year after dLVAD implantation. The following risk factors for 1-year mortality were identified: age (OR 1.02), specifically age over 55 years (OR 1.09), BMI >30 kg/m² (OR 2.2), female sex (OR for male sex 0.4), as well as elevated total bilirubin (OR 1.13) and low platelet counts (OR 0.996). Conclusions During preoperative conditioning, efforts should be undertaken towards normalising platelet counts and liver function. Using the identified risk factors as a basis, we created a risk score to estimate 1-year mortality to optimise patient selection for dLVAD implantation, with the aim of improving the outcome in this critical patient population.Normogram 1y-mortality prediction scoreCIF death grouped by quartiles of score

Abstract 15087: First Clinical Trial in China to Evaluate the Efficacy and Safety of Moyoassist® Extra-VAD System

Cardiogenic shock(CS)is associated with significant morbidity and mortality. For patients unresponsive to medicinal treatment, an alternative is a mechanical circulatory support (MCS) system. In China, common treatments using short-term MCS include IABP and VA-ECMO, both methods found their limitations. Therefore, a better strategy must be proposed to improve prognosis in CS patients, such as extracorporeal VAD (Extra VAD). Here, we reported 40 patients' data collected from a prospective, multicenter, single group clinical trial conducted from July 2021 to Feb 2023, which aims to evaluate the efficacy and safety of MoyoAssist® Extra-VAD system. MoyoAssist® is developed based on fully magnetically levitated pump technology to temporarily support the left, right, or biventricular circulation of patients with acute heart failure and cardiogenic shock of all causes. Patients were recruited for various indications, with PCCS (50%) and BTT (32.5%) being the top two causes. A combination of median sternotomy (22.5%), peripheral venous cannulation (52.5%) and mini-incision (25%) were employed to implant the device. Especially, jugular vein cannulation was a pioneering approach proposed to enable patients’ early ambulation and recovery. MoyoAssist® Extra-VAD has demonstrated stable and sufficient circulation support without severe device associated adverse events. The mean support duration was 7d16hrs, and overall survival rate at 30-day follow up was 62.5%. Hemodynamics indicated improvement with increased MAP and reduced CVP in all sub-groups. Lactate has shown a significant decrease in the PCCS-survival group (3.95 vs. 1.05, p<0.05), indicating improved reperfusion of organ tissues. While AST has shown a significant drop in the BTT-survival group (67.10 vs. 56.17, p<0.05), indicating improved liver function. During the support, 3 patients with peripheral cannulation and 2 patients with mini-incision were able to ambulate early. The types of complication seen were similar to those reported with CentriMag, but the rates of bleeding (15%) and hemolysis (0%) were much lower. In conclusion, MoyoAssist® Extra-VAD has demonstrated its safety and efficacy for short-to-mid-term support of patients with acute heart failure and cardiogenic shock.

Advanced Treatment of Hemodynamically Unstable Acute Pulmonary Embolism and Clinical Follow-up.

High-risk acute pulmonary embolism (PE), defined as acute PE associated with hemodynamic instability, remains a significant contributor to cardiovascular morbidity and mortality in the United States and worldwide. Historically, anticoagulant therapy in addition to systemic thrombolysis has been the mainstays of medical therapy for the majority of patients with high-risk PE. In efforts to reduce the morbidity and mortality, a wide array of interventional and surgical therapies has been developed and employed in the management of these patients. However, the most recent guidelines for the management of PE have reserved the use of these advanced therapies in scenarios where thrombolytic therapy plus anticoagulation are unsuccessful. This is due largely to the lack of prospective, randomized studies in this population. Stemming from this, the approach to treatment of these patients varies widely depending on institutional experience and resources. Furthermore, morbidity and mortality remain unacceptably high in this population, with estimated 30-day mortality of at least 30%. As such, development of a standardized approach to treatment of these patients is paramount to improving outcomes. Early and accurate risk stratification in conjunction with a multidisciplinary team approach in the form of a PE response team is crucial. With the advent of novel therapies for the treatment of acute PE, in addition to the growing availability of and familiarity with mechanical circulatory support systems, such a standardized approach may now be within reach.

Outcome of patients supported with the HeartMate 3 after extracorporeal life support: On behalf of the Durable Mechanical Circulatory Support After Extracorporeal Life Support Study Group

ObjectivesThe Durable Mechanical Circulatory Support System After Extracorporeal Life Support registry is a multicenter registry of patients who were bridged from extracorporeal life support to a durable mechanical circulatory support system. Although numerous studies have highlighted the favorable outcomes after implantation of the HeartMate 3 (Abbott), the objective of our study is to examine the outcomes of patients who received HeartMate 3 support after extracorporeal life support. MethodsData of patients undergoing HeartMate 3 implantation from January 2016 to April 2022 at 14 centers were collected and evaluated. Inclusion criteria were patients with extracorporeal life support before HeartMate 3 implantation. The outcome was reported and compared with patients receiving other types of pumps. ResultsA total of 337 patients were bridged to durable mechanical circulatory support system after extracorporeal life support in the study period. Of those patients, 140 were supported with the HeartMate 3. The other types of pumps included 170 HeartWare HVADs (Medtronic) (86%), 14 HeartMate II devices (7%), and 13 (7%) other pumps (7%). Major postoperative complications included right heart failure requiring temporary right ventricular assist device in 60 patients (47%). Significantly lower postoperative stroke (16% vs 28%, P = .01) and pump thrombosis (3% vs 8%, P = .02) rates were observed in the patients receiving the HeartMate 3. The 30-day, 1-year, and 3-year survivals in patients receiving the HeartMate 3 were 87%, 73%, and 65%, respectively. ConclusionsIn this critically ill patient population, the survivals of patients who were transitioned to the HeartMate 3 are deemed acceptable and superior to those observed when extracorporeal life support was bridged to other types of durable mechanical circulatory support systems.

Аcute renal failure in patients with implanted LVAD in the early postoperative period

AKI is one of the major complications in the cardiac surgery group of patients in the world. In patients with LVAD in the short postoperative period, the situation with such a complication as AKI is associated with the state of hemodynamics and fluctuations in the parameters of the hemostasis system.
 The purpose of this scientific work is to analyze the state of the blood coagulation system and its response to therapy and complications in the early postoperative period in fifty patients with implanted devices for mechanical support of the left ventricle, left ventricle assist device, LVAD, in the Silesian Heart Disease, Poland. Patients were divided into two groups, a control group receiving classical anticoagulation targeted therapy (ATT), which included the most controlled monotherapy with heparin, after reaching the target values of APTT, the addition and transition to monotherapy with warfarin until reaching the target INR and ASA, and the main, research group, who received an alternative ATT consisting of the previous one with the addition of P2Y12-receptor blockers and Xa-factors.
 The results showed that the control group of patients with classical anticoagulant targeted therapy had greater mortality associated with AKI than the patients of the study group, and it was also demonstrated that the initially longer duration of surgery and intraoperative polyuria gave a greater percentage of AKI in the postoperative period.
 The work was carried out within the framework of a bilateral agreement on scientific cooperation between the Department of Anesthesiology & Intensive Care at the National Medical Academy of Post-Graduate Education Named After P.L. Shupyk and the Silesian Center for Heart Diseases (Poland). This article is part of the analysis of the work on the analysis of the blood coagulation system in patients after implantation of the left ventricular mechanical circulatory support system with the analysis of such postoperative complication as acute kidney failure.

Outcomes of patients with myocardial infarction and cardiogenic shock treated with culprit vessel-only versus multivessel primary PCI

Introduction and objectivesMultivessel primary percutaneous coronary intervention (pPCI) is still often used in patients with ST-elevation myocardial infarction (STEMI) and cardiogenic shock (CS). The study aimed to compare the characteristics and prognosis of patients with CS-STEMI and multivessel coronary disease (MVD) treated with culprit vessel-only pPCI or multivessel-pPCI during the initial procedure. Material and methodsFrom 2016 to 2020, 23,703 primary PCI patients with STEMI were included in a national all-comers registry of cardiovascular interventions. Of them, 1,213 (5.1%) patients had CS and MVD at admission to the hospital. Initially, 921 (75.9%) patients were treated with culprit vessel (CV)-pPCI and 292 (24.1%) with multivessel (MV)-pPCI. ResultsPatients with 3-vessel disease and left main disease had a higher probability of being treated with MV-pPCI than patients with 2-vessel disease and patients without left main disease (28.5% vs. 18.6%; p < 0.001 and 37.7% vs. 20.6%; p < 0.001). Intra-aortic balloon pump, extracorporeal membrane oxygenation (ECMO), and other mechanical circulatory support systems were more often used in patients with MV-pPCI. Thirty (30)-day and 1-year all-cause mortality rates were similar in the CV-pPCI and MV-pPCI groups (odds ratio, 1.01; 95% confidence interval [CI] 0.77 to 1.32; p = 0.937 and 1.1; 95% CI 0.84 to 1.44; p = 0.477). The presence of 3-vessel disease and the use of ECMO were the strongest adjusted predictors of 30-day and 1-year mortality. ConclusionsOur data from an extensive all-comers registry suggests that selective use of MV-pPCI does not increase the all-cause mortality rate in patients with CS-STEMI and MVD compared to CV-pPCI.

Short-term mechanical support with the Impella 5.x for mitral valve surgery in advanced heart failure-protected cardiac surgery.

Surgical treatment of patients with mitral valve regurgitation and advanced heart failure remains challenging. In order to avoid peri-operative low cardiac output, Impella 5.0 or 5.5 (5.x), implanted electively in a one-stage procedure, may serve as a peri-operative short-term mechanical circulatory support system (st-MCS) in patients undergoing mitral valve surgery. Between July 2017 and April 2022, 11 consecutive patients underwent high-risk mitral valve surgery for mitral regurgitation supported with an Impella 5.x system (Abiomed, Inc. Danvers, MA). All patients were discussed in the heart team and were either not eligible for transcatheter edge-to-edge repair (TEER) or surgery was considered favorable. In all cases, the indication for Impella 5.x implantation was made during the preoperative planning phase. The mean age at the time of surgery was 61.6 ± 7.7 years. All patients presented with mitral regurgitation due to either ischemic (n = 5) or dilatative (n = 6) cardiomyopathy with a mean ejection fraction of 21 ± 4% (EuroScore II 6.1 ± 2.5). Uneventful mitral valve repair (n = 8) or replacement (n = 3) was performed via median sternotomy (n = 8) or right lateral mini thoracotomy (n = 3). In six patients, concomitant procedures, either tricuspid valve repair, aortic valve replacement or CABG were necessary. The mean duration on Impella support was 8 ± 5 days. All, but one patient, were successfully weaned from st-MCS, with no Impella-related complications. 30-day survival was 90.9%. Protected cardiac surgery with st-MCS using the Impella 5.x is safe and feasible when applied in high-risk mitral valve surgery without st-MCS-related complications, resulting in excellent outcomes. This strategy might offer an alternative and comprehensive approach for the treatment of patients with mitral regurgitation in advanced heart failure, deemed ineligible for TEER or with need of concomitant surgery.

Pressure-strain loops unveil haemodynamics behind mechanical circulatory support systems.

Mechanical circulatory support (MCS) systems are increasingly employed in cardiogenic shock and advanced heart failure. A thorough understanding of the complex interactions occurring among heart, vasculature, and device is essential to optimize patient's management. The aim of this study is to explore non-invasive haemodynamic profiling of patients undergoing MCS based on pressure-strain (PS) analysis. Clinical and echocardiographic data from consecutive patients undergoing different MCS systems positioning/implantation admitted to the third level cardiological intensive care unit of Siena Hospital from August 2021 to November 2021 were retrospectively reviewed. Patients without a useful echocardiographic exam or without arterial blood pressure recording at the time of echocardiography were excluded. Myocardial work analysis was performed in the included patients. We reviewed 18 patients, of which nine were excluded. Included patients were three patients with intra-aortic balloon pump (IABP), two patients with durable left ventricular assist device (dLVAD), two patients with Impella®, one patient with extracorporeal membrane oxygenation (ECMO), and one patient with ECMO and IABP. Myocardial work analysis was feasible in each included patient. The use of IABP shifted the PS curve rightward and downward. Global work index (GWI) and global wasted work (GWW) decreased after IABP positioning, whereas global work efficiency (GWE) increased. The use of continuous-flow pumps, whether temporaneous (Impella®) or long term (dLVAD), induced a change in the PS loop morphology, with a shift towards a triangular shape. ECMO positioning alone resulted in a narrowing of the PS loop, with a decrease in GWI and GWE and an increase in GWW and mean arterial pressure. The combined used of IABP with ECMO widened the PS loop and improved GWI and GWE. PS loops analysis in patients undergoing MCS seems to be feasible and may unveil MCS-induced haemodynamic variations. Myocardial work could be used to monitor ventricular-arterial-device coupling and guide tailored MCS management.

P39: Generational Status as a Factor in Medical Device Information and Data Exchange

Background: Medical devices (MD), either implantable, such as mechanical circulatory support systems, or wearable, i.e. motion/physiologic sensors, are increasingly utilized for diagnostic/therapeutic purposes. For maximal use efficacy and efficiency, MDs require individual compliance and adherence to operating instructions and data exchange. In today’s world we have increasingly shifted from paper-based information transfer (data sheets, directions for use, etc.) to periodic downloads, and web- and social media-based wireless communication. With growth of MD use it has become evident that a disconnect exists in the tactics employed by device designers and manufacturers compared with patient end-users. This disconnect relates to the form and means of communication utilized to convey and extract information versus patient facility with computer, smartphone and social media information exchange. As a starting point in examining this problem, we studied this disconnect as it relates to individual “generational” status. We conducted an anonymous survey, to examine “generational ” familiarity, acceptance and use; focusing on wearable technology and web-based information sources. Methods: An anonymous survey was developed and distributed to individuals ranging in age from 19 to 78, equally split as to gender. Generations examined included: Silent (age 74-91); Boomers (age 55-73), Gen X (age 39-54), Millennials (age 23-38), and Gen Z (age 7-22). Participants were queried via 10 multiple-choice questions related to digital health, wearable technologies and telemedicine. Results: Eighty-seven individuals participated in the survey. As to generational breakdown, this included 4 Silent (5% of group), 12 Boomers (14% of group), 9 Gen X (10% of group), 38 Millennials (43% of group) and 24 Gen Z (28% of group). Overall younger individuals tended to utilize and believed in the greater accuracy of wearable technologies compared to older individuals. Up to 90% of individuals under the age of 40 believed in the accuracy of wearable technology. Out of the 87 individuals surveyed, 95% reported they were comfortable with their personal health data (labs, imaging, medications, etc.) being shared electronically, but not a single individual believed that digital health/telemedicine improved their quality of care when compared to in-person medical care. Conclusions: Our results reveal that although all individuals are willing to utilize wearable medical technology and web-based information sources, younger generational cohorts are significantly more comfortable with the technology and more inclined to use it. Our hope is that this data may help guide future device development to incorporate means of addressing these generational disparities. Incorporating means of enhancing familiarity, adoption and facility of digital medical devices technologies and web-based information sources, will continue to improve use and value of these devices driving precision medicine.

CARD29: Sodium Bicarbonate as an Adjunctive Local Anti-Thrombotic Agent for Cardiovascular Therapeutic Devices

Purpose: Despite clinical efficacy, mechanical circulatory support (MCS) systems remain challenged in maintaining physiologic hemostatic balance. The Impella heart pump is a micro-axial percutaneous MCS device that utilizes a purge flow for maintaining bearing lubrication, purge patency, and anti-thrombosis purposes, forming a purge gap micro-environment wherein purge fluid and blood may mix. During operation, a continuous 5% dextrose in water (D5W) + heparin purge solution flows through the Impella catheter to inhibit protein adsorption and thrombosis in internal purge gaps. This exogenous heparin can increase bleeding risk and complicate systemic heparin and anticoagulation management. Recent FDA approval has made available sodium bicarbonate (SB) as an alternative to purge heparin. Despite promising early clinical results, the influence of SB on blood platelets, central mediators of thrombosis and bleeding, remains unclear. Here, we investigated the effect of SB on human platelet function (adhesion, aggregation, activation) in vitro following incubation with relevant concentrations of heparin or SB. Methods: Human gel-filtered platelets (20,000/µL) or platelet rich plasma (100,000/µL) were obtained from ACD-A anticoagulated whole blood. Platelets were incubated (6:4 platelets: purge) at 37°C for 15 min with purge solutions (D5W; 50U/mL heparin + D5W; 25mEq/L SB + D5W; 50mEq/L SB + D5W; 100mEq/L SB + D5W). Platelet activation was measured as thrombin generation rate utilizing a previously-described modified prothrombinase assay. Platelet adhesion was measured via imaging (Nikon DS-Qi2; 100X) of fluorescent-labelled platelets (BioTracker490) adhered to glass. Platelet aggregation was quantified from agonist-mediated aggregation using a light-transmission aggregometer (PAP8E). All experiments were performed in duplicate with N≥3 donors. Results: SB altered overall platelet function in a concentration-dependent manner. 100mEq/L SB led to a significant decrease in platelet adhesion (0.11% decrease; Fig 1A), whereas only 25mEq/L SB led to a significant reduction in thrombin generation rate (14.0% decrease; Fig 1B). Collagen-mediated aggregation was significantly reduced after addition of 100mEq/L SB (42.2% decrease; Fig 1C). Traditional D5W+heparin solution significantly reduced platelet function, in all categories, to a greater degree than 25mEq/L SB, but had a similar effect to 50 or 100mEq/L SB when comparing platelet adhesion and activation metrics. Conclusion: SB in the concentrations tested led to altered platelet function, modulating surface adhesion, activation, and collagen-mediated aggregation –useful effects to limit device fouling and purge gap thrombosis. Use of SB as a localized anti-thrombotic agent, where its concentration and effect are not rapidly diluted, is promising for MCS such as the Impella system. SB use offers the potential for locally limiting thrombogenicity at the purge gap, while avoiding the need for exogenous heparin.

Advances in Extracorporeal Support Technologies in Critically Ill Children.

The field of pediatric heart failure is evolving, and the patient population is growing as survival after complex congenital heart surgeries is improving. Mechanical circulatory support and extracorporeal respiratory support in critically ill children has progressed to a mainstay rescue modality in pediatric intensive care medicine. The need for mechanical circulatory support is growing, since the number of organ donors does not meet the necessity. This article aims to review the current state of available mechanical circulatory and respiratory support systems in acute care pediatrics, with an emphasis on the literature discussing the challenges associated with these complex support modalities.